What is the evidence to date, and what gap in knowledge is this trial trying to fill?

What is the study’s conclusion?

What is the application to practice?

i.e. what is the inclusion and exclusion criteria, and what are the actual/final patients randomized? How are they similar or different to my patient population?

Be specific with my conclusion (e.g. what kind of patients, what kind of monitoring, what kinds of concomitant interventions, etc.)

Important to consider how the design of the trial affects the conclusion that I can make about the study. This study was designed as a superiority trial and primary outcome is NSS; however, we cannot say that the two options are comparable as it has not deemed to be non-inferior (non-inferiority trials require more numbers than superiority trial and per-protocol analysis is more conservative in non-inferiority trials)